MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® WOVEN URETERAL CATHETER

Model Number 36303

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the 2 or 3 male external catheters had fallen off because of not enough adhesive and sometimes they did not roll down right and would stick to itself and knot up if some have too much glue and sometimes the patient had leak if there was not enough adhesive on them.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be "mechanical failure".The lot number was unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labelling could not have prevented the reported failure.The device was not returned.

Event Description

It was reported that the 2 or 3 male external catheters had fallen off because of not enough adhesive and sometimes they did not roll down right and would stick to itself and knot up if some have too much glue and sometimes the patient had leak if there was not enough adhesive on them.

• Brand Name: BARD® WOVEN URETERAL CATHETER
• Type of Device: URETERAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15152723
• MDR Text Key: 302700293
• Report Number: 1018233-2022-05984
• Device Sequence Number: 1
• Product Code: EYB
• UDI-Device Identifier: 00801741071065
• UDI-Public: (01)00801741071065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 36303
• Device Catalogue Number: 36303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male